Recall Z-0788-2022— Microbiologics Inc

Name: FDA recall Z-0788-2022
Creator: U.S. Food and Drug Administration
Published: 2015-07-17

Class III · Completed

Class III FDA medical device recall by Microbiologics Inc, initiated 2015-07-17. It names one FDA 510(k) clearance: K861022. Product: LYFO Disk. Reason: LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results..

Recalling firm: Microbiologics Inc
Classification: Class III
Status: Completed
Initiated: 2015-07-17
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LYFO Disk

Reason for recall

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.